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Judge Rules Breast Implant Evidence Invalid

A Federal judge who is overseeing breast implant cases in Oregon has ruled that lawyers cannot introduce evidence saying that implants cause disease, because such evidence is not scientifically valid. He also said that Oregon women with implants cannot sue manufacturers saying they fear they will become ill.

The judge dismissed 70 claims, and his ruling, if upheld on appeal, would stop scores of others from reaching the courts. Never before, experts say, has a science hearing of this kind affected so many claims all at once. Legal experts said that the ruling, if upheld, is likely to have a major impact on the tens of thousands of breast implant cases awaiting trial across the country, encouraging other judges to look more closely at the scientific foundation of the evidence that plaintiffs' lawyers want to introduce in court.

In his decision, Federal District Court Judge Robert E. Jones made clear that he was mindful of the scope of his opinion, which, he wrote, ''goes further in evaluating and eliminating plaintiffs' claims than any other opinion in breast implant litigation pending in this country.''

The ruling has significance beyond breast implant litigation, said Bert Black, a Dallas lawyer who is chairman of the American Bar Association's section on science and technology. ''It's also an important example to other courts on how to handle scientific issues,'' Mr. Black said.

Some legal experts said the ruling was a stunning blow to plaintiffs' lawyers who had argued that breast implants cause disease. ''This is absolutely critical,'' said Michael Green, a law professor at the University of Iowa in Iowa City. ''The plaintiffs' lawyers have got to be devastated by this ruling,'' he added.

Keith E. Tichenor, a Portland lawyer who represents about 20 women whose claims were dismissed by Judge Jones, called the ruling ''very disappointing.'' His clients, he said, ''want their day in court.'' As long as this opinion stands, he said, they will not have it.

But Frederick Ellis, a Boston lawyer who was the lead lawyer for the Oregon plaintiffs, and who represents a total about 200 women in suits against implant manufacturers, said that Judge Jones ''has misunderstood the law,'' in assessing scientific conclusions rather than simply the methods by which the science was done. He added that he is certain the ruling will be reversed upon appeal.

As many as a million American women had silicone breast implants and, in the past decade, tens of thousands of them have sued implant manufacturers claiming that silicone leaked from the devices, oozed throughout their bodies, and made them ill. The diseases ranged from classic auto-immune diseases, like lupus or scleroderma, to what the women said was a new disease, with symptoms like fatigue, headache, and muscle aches and pains.

In cases that have gone to court, women have won verdicts as high as $25 million. But many more cases were settled out of court for undisclosed amounts. The vast amount of litigation was so overwhelming to the major implant manufacturer, Dow Corning Corporation, that it declared bankruptcy. Three other makers of silicone implants, Bristol-Myers Squibb, Minnesota Mining and Manufacturing, and Baxter International, negotiated a plan in Federal court in Alabama that may result in a total settlement of $2 to $3 billion.

Judge Jones was responsible for all of the Oregon's silicone breast implant cases that were filed in Federal district court. In considering about 70 of those cases, he asked the lawyers for the plaintiffs and the defense to provide him with a list of expert witnesses that they would call. In July, the companies that are being sued, Baxter Healthcare and Bristol-Myers, asked the judge to exclude the scientific testimony from the plaintiffs' witnesses on the grounds that it was not based in science.

In 1993, in Daubert v. Merrell Dow Pharmaceuticals, a case involving Bendectin, a morning-sickness drug that was alleged to cause birth defects, the Supreme Court instructed courts to aggressively screen out what they found to be ill-founded or speculative scientific theories.

''The Supreme Court charged district courts with the duty to act as 'gatekeepers' to insure that any and all scientific testimony or evidence admitted is not only relevant but reliable,'' Judge Jones wrote in his opinion. And that, he added, means determining ''whether the reasoning or methodology underlying the testimony is scientifically valid'' and ''whether that reasoning or methodology can properly be applied to the facts in issue.''

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Judge Jones decided to ask a panel of disinterested scientists to advise him on the plaintiffs' evidence. After screening dozens of potential candidates, he finally selected ''four totally unbiased and uncommitted experts in the necessary fields,'' he wrote. The experts were Dr. Merwyn R. Greenlick, an immunologist, Dr. Robert F. Wilkens, a rheumatologist, Dr. Mary Stenzel-Poore, an immunologist and toxicologist, and Dr. Robert McClard, a polymer chemist.

He asked the scientists to study the scientific papers and documents submitted by the plaintiffs and then he held a hearing. It ''spanned four intense days'' in August, Judge Jones wrote, during which 12 experts for the plaintiffs and the defense were questioned by lawyers for both sides, by the court, and by the panel of scientists. Finally, the scientists provided their assessments of the plaintiff's scientific evidence. In his opinion, released late Tuesday, Judge Jones concluded that none of it was of sufficient quality to be presented in court.

While Judge Jones was deliberating, Federal Judge Samuel Pointer of Alabama, who is overseeing implant cases there, appointed a science panel of his own to advise him of the worthiness of plaintiffs' evidence that implants were harmful. His decision is not expected for about a year.

John McGoldrick, general counsel for Bristol-Myers, said he sees the decision as a ''major blow to false science in this area.'' And, he said, ''I think it will have a major impact,'' on judges' decisions in other courtrooms.

At Dow Corning, a spokesman, T. Michael Jackson, said the company was very happy with the Oregon decision. The ruling ''moves science to the forefront,'' he said, and keeps the focus on cause and effect, not emotional stories of ruined health.

Dow Corning is facing its creditors in bankruptcy court and on Dec. 2, asked that a jury decide, in a ''science trial,'' whether silicone causes disease. If a jury finds it does not, the company says, it would set aside $600 million for implant claims rather than the $2 billion it would otherwise set aside. Under that plan Dow Corning would pay for some physical problems caused by silicone breast implants or other medical devices containing silicone but not for autoimmune diseases or other illnesses.

Law professors say that the Oregon ruling may have far-reaching effects.

Peter Shuck, a law professor at Yale University School of Law, said he is unaware of any other ruling on scientific evidence that, in one swoop, ''has precluded so many claims.'' Mr. Schuck said he expected other judges might now follow Judge Jones' lead. ''It will certainly make more judges willing to take this step,'' he said.

Mr. Green said that the breast implant situation is beginning to remind him of what happened in the courts when about a decade ago when a surge in lawsuits over Bendectin began to subside..

After a few years, Mr. Green said, a few courts began dismissing Bendectin cases, saying there was no scientific evidence that the drug hurt fetuses. Other courts took notice. And soon, Mr. Green said, ''it became a landslide, a snowball.''

The ruling by Judge Jones, ''I would speculate, is the beginning of that snowball,'' he said.